Future of diabetes drug in doubt

Hearings continue today in the United States on whether a diabetes drug linked to heart failure should remain on the market – leaving future availability of the medication in the UAE uncertain.

Avandia (scientifically known as rosiglitazone maleate) – a drug used for the treatment of type-2 diabetes – has come under fire worldwide after new independent studies revealed that it was linked to heart failure and increased risk of death.

Its manufacturer, GlaxoSmithKline (GSK), is also under intense scrutiny after The New York Times reported that it hid test data on the cardiovascular risks of Avandia.

GSK confirmed that the US Food and Drug Administration (FDA) Advisory Committees were convening yesterday and today to review all the latest available data on Avandia.

Dr Tony Hoos, European Medical Director for GlaxoSmithKline maintained, “GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate Type 2 diabetes patients.”

Additionally, the European Medicines Agency (EMA), and the Committee for Medicinal Products for Human Use (CHMP) is also to review the benefit and risk profile of Avandia during its scheduled meeting between July 19 to 22.

SAUDI BAN

In 2007, an analysis of dozens of studies first linked the drug to heart attacks but the FDA responded by adding a warning label to the drug later that year.

Now, the FDA and EMA will consider a range of other options, including whether the medicine should be pulled from the market.

Should either committee confirm it indeed poses an increased danger compared to similar drugs, it is likely that Avandia will be pulled from the UAE and the rest of its Middle Eastern markets.

The UAE currently has the second highest rate of diabetes in the world, with over 20 per cent of the population reported to have the disease. According the Ministry of Health, diabetes-related heart ailments accounted for 31.6 per cent of deaths in the UAE in 2008, and that it costs the country between $100 million (Dh367m) to $200m annually for treatment alone.

According to GSK’s figures, the number of patients using Avandia within the APJEM region (Asia Pacific, Japan and Emerging markets) is currently approximately 750,000. At the GOLD diabetes meeting held in Dubai last March, it was reported that 50,000 patients use Avandia in the Middle East.

Interestingly, Saudi Arabia’s Food and Drug Authority (SDFA) banned Avandia for six months in May, citing growing evidence from clinical studies indicating serious cardiovascular risks.

However, the drug is still available in the UAE, and retails from Dh140.

SAFE OR UNSAFE?

According to more than 700 pages of documents prepared for the July 13-14 advisory panel meeting, scientists will review dozens of studies of Avandia, including one GSK has pointed to as proof of the drug’s safety.

And scientists and doctors are torn over it.

The Associated Press reported that FDA scientists have blasted a study by GSK used to defend the safety of the medication.

In fact, one FDA reviewer said the study actually makes the case against leaving Avandia on the market.

Dr. Thomas Marciniak, a medical team leader in the FDA division that reviews heart drugs, said that the trial was “inadequately designed and conducted to provide any reassurance about” the cardiovascular risks of Avandia.

Moreover, according to documents obtained by the New York Times, GSK conducted a study that showed Avandia was riskier to the heart than competing drugs – but instead of publishing the results, the company spent the next 11 years trying to cover them up.

GSK reportedly did not post the results on its website or submit them to federal drug regulators, as is required in most cases by law.

“This was done for the U.S. business, way under the radar,” Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results obtained by The Times. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK,” the corporate successor to SmithKline.

REGIONAL DEFENCE

However, in this region, medics have leapt to the drug’s defence.

Dr M. Belal Al Shammaa, Diabetologist and Endocrinologist at the American Hospital expressed his support of the product at a recent meeting telling Emirates Business: “This issue regarding Avandia has already been dealt with by the well executed RECORD trial.

“This trial was specifically designed to answer any questions surrounding Avandia and cardiovascular risk which resulted in very strong margin of confidence being presented that any linkage was not an issue. Why the issue is being brought up again is not clear.”

Meanwhile, Dr. Khalid Al-Rubeaan, director of the Diabetes Center at King Saud University (KSU) in Saudi Arabia said of its ban in his country: “I think it was a wrong decision, and I hope the SFDA will reverse the decision shortly.”

A spokesperson for GSK said it “was too early to speculate” on whether the drug will be pulled from the market.

Claire Brough, Director of Media, Global News Strategy told Emirates Business: “GSK has already disclosed all of its information supporting Avandia. We cannot give further comment until after the FDA’s meeting.”

Avandia works by increasing the body’s sensitivity to insulin, a key protein needed for digestion that diabetics don’t adequately produce.

In 2006, it became GSK’s best-selling drug with a US revenue of $2.2 billion. However, safety concerns swirling around the drug have pummelled sales over the last three years, falling 75 per cent to $520 million last year.

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